BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX)

    MDR report key: 3654332 · Received March 3, 2014

    Report

    Report Number
    0002936485-2014-00092
    Event Type
    Malfunction
    Date Received
    March 3, 2014
    Date of Event
    February 3, 2014
    Report Date
    February 3, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GFF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT PHYSICALLY RETURNED FOR INVESTIGATION. HOWEVER, BASED ON THE PICTURES PROVIDED BY THE CUSTOMER WE CAN CONSIDER THE REPORTED FAILURE MODE CONFIRMED. BASED ON THE PICTURES, IT IS READILY APPARENT THAT THERE WAS A TIP BREAKAGE. THE TIP BROKE AT THE METAL SHAFT NOT AT THE WELDING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) OF THE IMPLICATED LOT NUMBER DID NOT INDICATE ANY MANUFACTURING ISSUES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE. FURTHERMORE THERE HAVE BEEN NO RECENT MANUFACTURING OR DESIGN CHANGES TO THIS DEVICE RELATED TO THE FAILURE MODE. MOST PROBABLE ROOT CAUSE(S) FOR THE REPORTED FAILURE MODE CAN BE ASSOCIATED, BUT NOT LIMITED TO: POOR SUCTION, EXCESSIVE FORCE APPLIED BY USER, SHAVER BLADE COMES IN CONTACT WITH A METAL OBJECT (I.E. SCOPE) AND/OR SETTINGS USED ABOVE THE RECOMMENDED LIMITS. IN SUM, THE PRODUCT WAS NOT PHYSICALLY RETURNED FOR INVESTIGATION BUT BASED ON THE PICTURES PROVIDED, WE CAN CONSIDER THE REPORTED FAILURE MODE CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DISPOSABLE ARTHROSCOPY BLADE BROKE OFF THE END DURING SURGERY. THE BLADE DID NOT BREAK INTO FRAGMENTS AND THE WHOLE BROKEN PART WAS RETRIEVED FROM THE PATIENT RESULTING IN A DELAY OF APPROXIMATELY FIVE MINUTES. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DISPOSABLE ARTHROSCOPY BLADE BROKE OFF THE END DURING SURGERY. THE BLADE DID NOT BREAK INTO FRAGMENTS AND THE WHOLE BROKEN PART WAS RETRIEVED FROM THE PATIENT RESULTING IN A DELAY OF APPROXIMATELY FIVE MINUTES. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126226 4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX) BUR, SURGICAL, GENERAL & PLASTIC SURGERY GFF STRYKER ENDOSCOPY-SAN JOSE 13312CE2

    Patients

    Seq Age Sex Outcome Treatment
    1